Zimmer Receives FDA Clearance For Patient Specific Instruments (PSI) Shoulder
WARSAW, Ind., Aug. 23, 2013 /PRNewswire/ -- Zimmer Holdings, Inc. (NYSE: ZMH; SIX: ZMH), a world leader in musculoskeletal care, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the Zimmer®Patient Specific Instruments (PSI) Shoulder system to complement its Trabecular Metal Reverse Shoulder system for reverse shoulder arthroplasty (RSA) procedures. Zimmer PSI Shoulder utilizes 3D visualization software to allow a surgeon to create a customized surgical plan for each patient, and then provides patient-specific surgical instrument guides to facilitate placement of the implant corresponding to the personalized surgical plan. Zimmer PSI Shoulder has been available to a limited number of surgeons in Europe since May and it will now be made available to shoulder surgeons across the United States.
“Reverse Shoulder Arthroplasty has helped restore function and alleviate pain for thousands of patients each year,” said Roberto Munoz, Vice President and General Manager, Zimmer Extremities. “But the primary challenges remain on the glenoid. With PSI Shoulder, we present our surgeon customers with a powerful new tool to plan the glenoid side of the surgery with the patient’s unique anatomy in full view and functional needs in mind, resulting in a physical reference in the operating room to complete the surgery with confidence.”
Developed in collaboration with surgeons worldwide, Zimmer® PSI Shoulder enables the surgeon to plan the implant size and position, as well as the bone preparation, even the positioning of the screws.
“Zimmer’s PSI Shoulder makes you look at the patient in an entirely different way,” said Dr. Olivier Verborgt, of AZ-Monica hospital, Antwerp Belgium, who has performed several Zimmer PSI Shoulder cases to date.“The planning software and patient-specific instrument guides help you think about what you want to do in the OR, and then actually do it.”
Zimmer® PSI Shoulder is designed to complement Zimmer’s Trabecular Metal Reverse base plate implant system, which has been leading the RSA market for the last two years. Zimmer’s proprietary Trabecular Metal Technology is designed to provide optimal porosity and a friction fit for the implant into the glenoid bone, while supporting biologic ingrowth.[1],[2]
About the Company
Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer designs, develops, manufactures and markets orthopaedic reconstructive, spinal and trauma devices, dental implants, and related surgical products. Zimmer has operations in more than 25 countries around the world and sells products in more than 100 countries. Zimmer’s 2012 sales were approximately $4.5 billion. The Company is supported by the efforts of more than 9,000 employees worldwide.
For more information about Zimmer, visit www.zimmer.com
Zimmer Safe Harbor Statement
This press release contains forward-looking statements within the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 based on current expectations, estimates, forecasts and projections about the orthopaedics industry, management’s beliefs and assumptions made by management. Forward-looking statements may be identified by the use of forward-looking terms such as “may,” “will,” “expects,” “believes,” “anticipates,” “plans,” “estimates,” “projects,” “assumes,” “guides,” “targets,” “forecasts,” and “seeks” or the negative of such terms or other variations on such terms or comparable terminology. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that could cause actual outcomes and results to differ materially. For a list and description of such risks and uncertainties, see our periodic reports filed with the U.S. Securities and Exchange Commission. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be set forth in our periodic reports. Readers of this document are cautioned not to place undue reliance on these forward-looking statements, since, while we believe the assumptions on which the forward-looking statements are based are reasonable, there can be no assurance that these forward-looking statements will prove to be accurate. This cautionary statement is applicable to all forward-looking statements contained in this document.
[1] Bobyn JD, et al. Characterization of a new porous tantalum biomaterial for reconstructive orthopaedics. Scientific Exhibition: 66th Annual Meeting of the American Academy of Orthopaedic Surgeons; 1999; Anaheim, CA.
[2] Journal of Musculoskeletal Research. 1999; 3: 245-251.
SOURCE Zimmer Holdings, Inc.
Help employers find you! Check out all the jobs and post your resume.
